The number of women living with metastatic breast cancer in the U.S. is estimated to be over 150,000, and Sheri Delmonte-Maloney is one of them. She is a 36-year-old single mother of four and lives in Webster, NY. She has stage IV cancer, which has spread to her liver and the lymph nodes throughout her body. For nearly five years she has endured multiple surgeries, radiation and chemotherapies at nearby Roswell Park Cancer Institute, but the cancer keeps coming back.
Having failed the latest treatment, and out of other options, she has found alternative treatment available in Germany which costs $30,000. YouCaring.com is fundraising on her behalf and there is a fundraiser in New York on September 13th at the Wall Street Bar and Grill.
I don’t know Sheri’s particular medical history, but metastatic breast cancer in a young woman is often on the basis of a mutation to a BRCA gene. The FDA is playing a significant role both in facilitating and also limiting the approval of new treatments for stage IV breast cancer. There is current exciting research ongoing in targeted treatments that block the growth of these tumors, provoke the immune system to attack them, or block the cancer stem cells that create the tumors. One promising treatment, called a PARP inhibitor, blocks DNA repair of cancer cells. This treatment is particularly promising in BRCA tumors because they have already had difficulty repairing their DNA in order to continue to grow. But PARP inhibitors are not yet approved for use outside of clinical trials.
As studies continue on these drugs, the FDA monitors the trials for side effects as well as effectiveness, but for a patient like Sheri who is out of options, approval for new treatments or even unproven alternative treatments like mistletoe or thymus peptide injections can’t come fast enough.
I understand the need for the FDA to adhere to scientific methods, but I also understand the need for a cancer patient to have alternatives and to be able to maintain hope.
Marc Siegel, M.D. is a professor of medicine and medical director of Doctor Radio at NYU Langone Medical Center. He has been a medical analyst and reporter for Fox News since 2008.